NCT04910711 (CODA) is a Phase 4 clinical trial of Dolutegravir in Human Immunodeficiency Virus, sponsored by Botswana Harvard AIDS Institute Partnership.

Who is sponsoring NCT04910711?

NCT04910711 is sponsored by Botswana Harvard AIDS Institute Partnership.

What drugs are being tested in NCT04910711?

Interventions in NCT04910711: Dolutegravir, Levonorgestrel implant, Depo medroxyprogesterone acetate injection.

What condition does NCT04910711 study?

NCT04910711 studies Human Immunodeficiency Virus, Contraception, ART.

Is NCT04910711 still recruiting?

NCT04910711 is currently status unknown. Last updated 27 July 2023.

Last reviewed 2023-07-27 · How we verify

NCT04910711: CODA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Investigating the Interaction Between Two Long-acting Reversible Methods of Contraception and Dolutegravir, a Treatment for HIV

Status unknown Phase 4 Last updated 27 July 2023

What this trial tests

Phase 4 trial testing Dolutegravir in Human Immunodeficiency Virus in 140 participants. Status unknown.

Timeline

21 October 2021

Primary endpoint
31 August 2023

31 October 2024

Quick facts

Lead sponsor	Botswana Harvard AIDS Institute Partnership
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	140
Start date	21 October 2021
Primary completion	31 August 2023
Estimated completion	31 October 2024
Sites	1 location across Botswana

Drugs / interventions tested

Dolutegravir (DOLUTEGRAVIR) — full drug profile →
Levonorgestrel implant — full drug profile →
Depo medroxyprogesterone acetate injection

Conditions studied

Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
Contraception — all drugs for Contraception →
ART — all drugs for ART →

Sponsor

Botswana Harvard AIDS Institute Partnership

Who can join

Adults 18 to 45, female only, with Human Immunodeficiency Virus or Contraception. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It is important to make sure that women have access to effective methods of contraception to prevent pregnancy so that they can make choices about when and if they will have their first or next child. Some of the most effective methods of contraception are the long-acting, reversible methods of contraception (LARCS), including the contraceptive implant and the contraceptive injection. In areas of the world where there are high numbers of people living with HIV, providing contraception to women is sometimes complicated, as there are known to be interactions between some of the medications that treat HIV and some hormonal methods of contraception. One medication to treat HIV, dolutegravir, is now one of the first-line treatments for HIV in Botswana, and more and more women of childbearing age are taking dolutegravir to treat HIV. At the moment, there is limited information on whether or not there are interactions between dolutegravir (the HIV medication) and the contraceptive implant or the contraceptive injection, two commonly used methods of contraception in Botswana. The main purpose of this study is to find out if women using contraception and also taking dolutegravir have lower levels of contraceptive hormone in their blood compared to women taking no HIV treatment. The study hypothesis is that there is no interaction between dolutegravir and the contraceptive implant or injection. In this study, levels of hormone from the injection or the implant will be measured in women living with HIV who take dolutegravir and compared to hormone levels in women who do not have HIV and who have never taken any medications to treat HIV. Women will be counselled about all of the possible methods of contraception (including the pill, the injection, the implant and the copper intrauterine device (or coil/loop)) that are available and will be empowered to make their own decision about the method of contraception they feel will be best for them. Women who choose the implant or the injection will be invited to enrol in the study; and will be categorised into one of four groups, based on whether or not they are living with HIV and taking dolutegravir. At several time points, women will have blood tests to check the level of hormone from the implant or the injection, over a course of 12 weeks for women starting the injection and 24 weeks for women starting the implant. Women will also be asked to complete a short questionnaire about any side effects from the contraception including changes to bleeding patterns. At the end of the 12 weeks (for women starting the injection) or 24 weeks (for women starting the implant), the results from these blood samples will be analysed to see how the levels of the hormone in their blood changed over time. The study will also look at whether the levels of dolutegravir (the HIV medication) changed over time. These results will be compared between women living with HIV taking dolutegravir and women without HIV who have never taken dolutegravir to see whether there is any interaction between dolutegravir and the hormonal contraceptive implant or contraceptive injection.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Currently open trials in the same condition.

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Other Botswana Harvard AIDS Institute Partnership trials

Trials by the same sponsor.

NCT06919614 — STI Testing to Enhance PrEP Use in Pregnancy · Phase 3 · recruiting
NCT05715944 — Incidence of COVID-19 Following Vaccination in Botswana Against SARS CoV 2 · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04910711 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Botswana Harvard AIDS Institute Partnership
Last refreshed: 27 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04910711.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing